140. Dorabe syndrome Clinical trials / Disease details
Clinical trials : 116 / Drugs : 65 - (DrugBank : 17) / Drug target genes : 50 - Drug target pathways : 64
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-205180 | 29/11/2012 | 25/02/2020 | Post-marketing surveillance of DIACOMITCapsule, Powder for Oral Suspension | Post-marketing surveillance of DIACOMIT (Capsule: 250 mg or 500 mg, Powder for Oral Suspension: 250 mg or 500 mg) | Dravet Syndrome | Intervention name : DIACOMIT (Stiripentol) INN of the intervention : stiripentol Dosage And administration of the intervention : Usually, for patients aged 1 year or older, 50 mg/kg of stiripentol per day is orally administered in divided doses two to three times a day during or immediately after a meal. Dosing starts at 20 mg/kg daily and is increased by 10 mg/kg at intervals of at least one week. However, for patients weighing 50 kg or more, start taking 1000 mg of stiripentol daily, and increase the dosage by 500 mg at intervals of one week or more. The maximum daily dose shall not exceed 50 mg/kg or 2500 mg, whichever is lower. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Meiji Seika Pharma Co., Ltd. | NULL | recruiting | BOTH | 300 | NA | Japan | ||
| 2 | EUCTR2007-001784-30-FR (EUCTR) | 19/07/2007 | 01/06/2007 | Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study. | Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study. | Antiepileptic | Trade Name: DIACOMIT Product Name: DIACOMIT Trade Name: DIACOMIT Product Name: DIACOMIT | BIOCODEX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France |